ADVERSE REACTIONS
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:
Burning | Hypertrichosis | Maceration of the Skin |
Itching | Acneiform Eruptions | Secondary Infection |
Irritation | Hypopigmentation | Skin Atrophy |
Dryness | Perioral Dermatitis | Striae |
Folliculitis | Allergic Contact Dermatitis | Miliaria |
To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
DOSAGE AND ADMINISTRATION
Fluocinonide Cream, USP 0.05% (Emulsified Base) is generally applied to the affected area as a thin film from two to four times daily, as needed.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
HOW SUPPLIED
Fluocinonide Cream, USP 0.05% (Emulsified Base) is supplied in 15 g (NDC 0115-1705-52), 30 g (NDC 0115-1706-45) and
60 g (NDC 0115-1707-58) Tubes.
Store at controlled room temperature 15°-30°C (59°-86°F). Do not refrigerate.
Manufactured by:
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080
Distributed by:
Impax Generics
Hayward, CA 94544
1933-01
GW 7140
Issued 08/2016
8-0664IMLNC1
PRINCIPAL DISPLAY PANEL — 0.05%, 15 G CREAM CARTON
NDC 0115-1705-52
15 g
PRINCIPAL DISPLAY PANEL — 0.05%, 30 G CREAM CARTON
NDC 0115-1706-45
30 g
PRINCIPAL DISPLAY PANEL — 0.05%, 60 G CREAM CARTON
NDC 0115-1707-58
60 g
FLUOCINONIDE fluocinonide cream |
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FLUOCINONIDE fluocinonide cream |
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FLUOCINONIDE fluocinonide cream |
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Revised: 10/2016 Impax Generics
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https://medlibrary.org/lib/rx/meds/fluocinonide-28/page/2/